(94 days)
The Impulse™ and Expo™ Angiographic Catheters are designed to provide a pathway to be used for delivering contrast media to selected sites in the vascular system during an angiographic procedure.
The Impulse™ and Expo™ Angiographic Catheters are single lumen catheters offered in Selective, Pigtail and Multi-Purpose models in 5F and 6F. The devices have multiple polymer layers with a stainless steel braid embedded between the layers. The atraumatic tip does not contain braid. The proximal end consist of an insert molded polymer hub and a strain relief.
This document is for an angiographic catheter and describes non-clinical testing. It does not include information about clinical studies or AI/ML device performance. Therefore, I cannot provide a table of acceptance criteria and reported device performance related to AI, nor can I answer questions about sample sizes, expert involvement, adjudication methods, MRMC studies, or standalone algorithm performance.
Here's the information that can be extracted from the provided text regarding the non-clinical testing:
Acceptance Criteria and Device Performance (Non-Clinical)
| Acceptance Criteria Category | Specific Test Performed | Reported Device Performance (as stated in the document) |
|---|---|---|
| Mechanical Bench Testing | Shaft Stiffness | "Design verification testing, including mechanical bench testing was performed to verify that the performance of the Impulse™ and Expo™ Angiographic Catheters remain substantially equivalent to both predicate devices." |
| Tip Bond Tensile Strength | "Design verification testing, including mechanical bench testing was performed to verify that the performance of the Impulse™ and Expo™ Angiographic Catheters remain substantially equivalent to both predicate devices." | |
| Shaft Integrity: Burst Pressure | "Design verification testing, including mechanical bench testing was performed to verify that the performance of the Impulse™ and Expo™ Angiographic Catheters remain substantially equivalent to both predicate devices." | |
| Hub Tensile | "Design verification testing, including mechanical bench testing was performed to verify that the performance of the Impulse™ and Expo™ Angiographic Catheters remain substantially equivalent to both predicate devices." | |
| Radiopacity | "Design verification testing, including mechanical bench testing was performed to verify that the performance of the Impulse™ and Expo™ Angiographic Catheters remain substantially equivalent to both predicate devices." | |
| Biocompatibility Testing | Cytotoxicity | "Biocompatibility...testing were also performed to verify the overall safety and efficacy of the device." |
| Hemolysis | "Biocompatibility...testing were also performed to verify the overall safety and efficacy of the device." | |
| FTIR (Fourier-transform infrared spectroscopy) | "Biocompatibility...testing were also performed to verify the overall safety and efficacy of the device." | |
| Latex | "Biocompatibility...testing were also performed to verify the overall safety and efficacy of the device." | |
| Sterility | Sterility Testing | "Sterility...testing were also performed to verify the overall safety and efficacy of the device." |
| Packaging | Packaging Testing | "Packaging testing were also performed to verify the overall safety and efficacy of the device." |
Key Findings from the Document:
- No Clinical Testing: The document explicitly states, "Clinical Evaluation was not required for these devices." This means there is no clinical study data to report for humans.
- Substantial Equivalence: The primary method for demonstrating safety and efficacy for this device was through substantial equivalence to predicate devices, supported by non-clinical testing. The performance goal for each non-clinical test appears to be demonstrating that the new device remains "substantially equivalent" to its predicates.
- Device Type: This is a diagnostic intravascular guide catheter, which is a physical medical device, not an AI/ML software device. Therefore, questions related to AI/ML specific performance metrics are not applicable.
Answers to Specific Questions (based on the provided text):
- A table of acceptance criteria and the reported device performance: See the table above. The performance reported is that the devices "remain substantially equivalent" to predicate devices for the listed tests.
- Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective): Not applicable for non-clinical bench testing. The document does not specify sample sizes for mechanical or biocompatibility tests, nor data provenance in terms of country or retrospective/prospective nature.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience): Not applicable. "Ground truth" in the context of clinical or AI studies does not apply to materials and mechanical bench testing.
- Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable. This refers to adjudication of medical opinions, which is not relevant for bench testing.
- If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: No. Clinical evaluation was not required, and this is not an AI device.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: No. This is not an AI algorithm; it is a physical medical device.
- The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not applicable. The "ground truth" for bench testing would typically be engineering specifications, material properties, and established laboratory standards that the device must meet or exceed. The document implies compliance to these standards to achieve "substantial equivalence."
- The sample size for the training set: Not applicable. There is no AI model, therefore no training set.
- How the ground truth for the training set was established: Not applicable.
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K120495
p. 1 of 1
MAY 2 1 2012
510(k) Summary
per 21 CFR §807.92
| Sponsor: | Boston Scientific CorporationOne Boston Scientific PlaceNatick MA 01760 |
|---|---|
| Contact Person: | Yumi Wackerfuss |
| Phone Number: | 763-255-0785 |
| Fax Number: | 763-494-2222 |
| Prepared: | 16 February 2012 |
| Trade Name: | Impulse™ and Expo™ Angiographic Catheter |
| Common Name: | Diagnostic Intravascular Guide Catheter |
| Classification: | II |
| Product Code: | DQO, 21 CFR 870.1200 |
| Predicate Device: | Impulse: K964859 (10 Feb 1997), K974559 (23 Feb 1998)Expo: K934581 (13 March 1994), K934541 (12 May 1994) |
Device Description
The Impulse™ and Expo™ Angiographic Catheters are single lumen catheters offered in Selective, Pigtail and Multi-Purpose models in 5F and 6F. The devices have multiple polymer layers with a stainless steel braid embedded between the layers. The atraumatic tip does not contain braid. The proximal end consist of an insert molded polymer hub and a strain relief.
Intended Use
The Impulse™ and Expo™ Angiographic Catheters are designed to provide a pathway to be used for delivering contrast media to selected sites in the vascular system during an angiographic procedure.
Substantial Equivalence
Modified Impulse™ and Expo™ Angiographic Catheter designs, materials, manufacturing processes and intended use are substantially equivalent to the predicate Impulse™ and Expo™ Angiographic Catheters.
Summary of Non-Clinical Testing
Design verification testing, including mechanical bench testing was performed to verify that the performance of the Impulse™ and Expo™ Angiographic Catheters remain substantially equivalent to both predicate devices. Biocompatibility, sterility, and packaging testing were also performed to verify the overall safety and efficacy of the device.
Specifically the following design verification was performed:
-
. Shaft Stiffness
. -
· · · · · · · · · · · · · Biocompatibility Testing ·
-
Tip Bond Tensile Strength
-
Shaft Integrity: Burst Pressure .
-
. Hub Tensile
-
Radiopacity .
-
-
Cytotoxicity
-
Hemolysis
- 本 FTIR
- 公 Latex
-
-
Summary of Clinical Testing
Clinical Evaluation was not required for these devices.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three tail feathers, representing the department's mission to protect the health of all Americans and provide essential human services. The eagle is encircled by the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" in a circular arrangement.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
MAY 2 1 2012
Boston Scientific Corporation c/o Ms. Yumi Wackerfuss Regulatory Affairs Specialist One Scimed Place Maple Grove, MN 55311
Re: K120495
Trade/Device Name: Impulse and Expo Angiographic Catheter Regulation Number: 21 CFR 870.1200 Regulation Name: Diagnostic Intravascular Catheter Regulatory Class: Class II Product Code: DQO Dated: April 3, 2012 Received: April 4, 2012
Dear Ms. Wackerfuss:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you; however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
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Page 2 - Ms. Yumi Wackerfuss
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely yours,
Bram D. Zuckerman, M.D.
Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use Form
510(k) Number (if known):
Device Name: Impulse™ and Expo™ Angiographic Catheter___
Indications for Use:
The Impulse™ and Expo™Angiographic Catheters are designed to provide a pathway to be used for delivering contrast media to selected sites in the vascular system during an angiographic procedure.
Prescription Use _____________________________________________________________________________________________________________________________________________________________ (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)
Burision Sign Off Office of In Vitro Diagnostic Device Evaluation and Safety
510(k) K120495
Page 1 of 1 ·
§ 870.1200 Diagnostic intravascular catheter.
(a)
Identification. An intravascular diagnostic catheter is a device used to record intracardiac pressures, to sample blood, and to introduce substances into the heart and vessels. Included in this generic device are right-heart catheters, left-heart catheters, and angiographic catheters, among others.(b)
Classification. Class II (performance standards).